Surgical or Catheter Ablations in Patients With Lone Atrial Fibrillation: Determination of Acute and Long Term Success Rate (SCALAF Success Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.
研究概览
简要总结
Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable monitoring device).
详细描述
Title: Surgical or Catheter Ablation in patients with Lone Atrial Fibrillation: determination of acute and long term SUCCESS (SCALAF-success trial).
Background: Anti-arrhythmic drugs are used in daily practice to treat patients with paroxysmal idiopatic AF. Often the origin of the AF can be found in the muscle sleeves running up the pulmonary veins. Drug treatment is not always successful and prone to evoke negative side effects. The surgical MAZE procedure was applied in the past, but this is a time consuming, cumbersome technique, often associated with significant complications. Cardiac radio-frequency ablation offers an alternative, easy and less time consuming treatment: lesions prevent normal electrical wave front propagation and might stop the continuation of atrial fibrillation wave fronts. Ablation can be implemented by use of special catheters inserted via the groin or using the Medtronic Cardioblate® Surgical Ablation System applied via minimal invasive surgical techniques.
Purpose: Compare the effectiveness of pulmonary vein isolation achieved via catheter or via surgical ablation techniques to treat patients with paroxysmal lone AF.
Study design: A prospective, randomized multi-center interventional study.
Patients: Patients suffering from paroxysmal idiopatic AF (no associated or underlying structural heart disease) complying with following inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines
- •Minimal one documented AF episode in the last 6 months
- •Refractory to minimal two Class I or III anti-arrhythmic drug
- •Age > 18 years
- •Signed and dated the Patient Informed Consent.
- •Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin)
排除标准
- •Patient has a structural heart disease
- •Ejection fraction < 40 %
- •Echocardiographic evidence for a left atrium > 45 mm (parasternal axis)
- •Patients on amiodarone, or patients known to be intolerant for amiodarone
- •Dextrocardia, current endocarditis, systemic infection, renal failure
- •Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA
- •Pregnancy at enrolment; or planned pregnancy within the follow up period
- •Patient has a life expectancy less than 1 year
- •The subject is participating in another device or drug study
- •The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
- •Echocardiographic (TTE) evidence for presence of left atrial thrombus
- •Previous (cardio-) thoracic surgery
- •Previous left atrial ablation
- •Patients with permanent or persistent AF
结局指标
主要结局
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.
时间窗: Baseline through 3-6 months post-ablation
AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.
次要结局
- Left Atrial Dimension and Contractility(Through 24 months post-ablation)
- Treatment Failures Requiring Redo or Alternative Therapy(Time from procedure until 6 months post-ablation)
- Number of Subjects With Adverse Events, Associated With the Ablation Procedure(Time from procedure)
- Duration, Burden and Costs of Treatment Procedures(Through 24 months post- ablation)
- Assessment of AF Burden(Through 24 months post-ablation)
- Reduced Anti-arrhythmic Drug Requirement(Through 24 months post-ablation)
- Occurences of Treatment of Arrhythmic Episodes(Through 24 months post-ablation)
- Mortality and Hospitalization(Time from procedure until 24 months post-ablation)
- Reduced Number, Duration and Severity of AF Symptoms(Through 24 months post-ablation)
- Symptoms Associated With Atrial Arrhythmias(Through 24 months post-ablation)